We are currently seeking a Biostatistician to be responsible for the preparation of PK, Statistical Analysis, and Statistical Reports for BA/BE and Phase I studies for various Regulatory submissions. Within the role you will:

• Provide statistical input and sample size calculations during protocol design
• Provide statistical/programming inputs for CRF design and review
• Generate randomization lists
• Prepare statistical analysis plans
• Perform blinded statistical review to check for data discrepancies
• Generate statistical analysis data sets
• Develop programming requirements documents for SAS programmers
• Perform data analysis and prepare statistical reports
• Generate data listings, tables, and graphs
• Develop programs for quality control of analysis programs
• Provide Statistical training to SAS programmers and knowledge sharing to statisticians
• Prepare integrated summaries of efficacy and safety, and answer regulatory queries
• Understand and comply with all SOPs
• Preparation of appendices in eCTD format

• 3 – 5 years of experience in BA/BE Studies